On August 16, 2012, the Federal Circuit issued, after remand from the Supreme Court, its opinion in The Association for Molecular Pathology v. Myriad Genetics, Inc., No. 2010-1406, slip opinion (Fed. Cir. August 16, 2012) ("Myriad"). The Supreme Court had vacated the Federal Circuit's prior opinion from 2011 and remanded the case for further consideration of the recent decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012) ("Mayo"). In Mayo, the Supreme Court held invalid certain medical method patent claims as effectively claiming laws of nature. In a decision largely following its prior ruling, the Federal Circuit concluded that the Mayo decision does not alter its previous findings. Therefore, the Federal Circuit held that claims directed to "isolated" DNA molecules are patent eligible under 35 U.S.C. §101. The Court also held that a method of screening cancer therapeutic candidates is patent eligible where the method includes the steps of "growing" transformed cells in the presence and absence of a therapeutic candidate and "determining" the cells' relative growth rates. On the other hand, methods comprising a step of "comparing" two gene sequences or "analyzing" a gene sequence are not patent-eligible absent an additional transformative step.
In May 2009, a group of medical organizations, researchers, genetic counselors, and patients ("Plaintiffs") filed suit against the University of Utah Research Foundation, Myriad Genetics and the U.S. Patent & Trademark Office ("PTO") seeking a declaratory judgment that fifteen claims related to aspects of BRCA diagnostic tests from seven patents assigned to Myriad were drawn to patent-ineligible subject matter under 35 U.S.C. §101. The challenged claims included (1) composition of matter claims directed to "isolated" DNA corresponding to the human BRCA genes (the "isolated DNA claims"), (2) method claims directed to methods of detecting cancer-predisposing mutations in a patient's BRCA genes (the "diagnostic method claims"), and (3) a method claim directed to a method of screening potential cancer therapeutics (the "screening method claim").
Myriad moved for summary judgment, arguing the Plaintiffs lacked standing to bring a declaratory judgment suit challenging the validity of its patents. The district court denied Myriad's motion and then granted summary judgment of invalidity to the Plaintiffs on all 15 claims, holding that the challenged claims were all drawn to patent-ineligible subject matter under §101. On appeal, the Federal Circuit affirmed in part and reversed in part. The Federal Circuit held that the isolated DNA claims and the screening method claim were patent eligible but the diagnostic method claims were not.
The Supreme Court vacated the Federal Circuit's prior decision and remanded the case for reconsideration in light of the recent Mayo decision.
The Federal Circuit's Ruling
Regarding the isolated DNA claims, the court asserted that Mayo does not apply to the question of patent-eligibility of claims directed to isolated DNA molecules. According to the court, claims to isolated DNA are claims to compositions of matter, which are expressly authorized as suitable subject matter in §101. The court stated whether isolated DNA is patent-eligible subject matter turns on whether the claims are directed to products of nature. The court held that claims to isolated DNA are not claims to products of nature. According to the court, human intervention is required to produce isolated DNA, such as cleaving or synthesizing a discrete portion of a native chromosomal DNA. The court noted that the isolation of DNA requires extensive research, as well as skill, knowledge, and effort, to isolate the particular portion of DNA to be isolated. Thus, claims drawn to isolated nucleotide fragments remain eligible for patent protection.
Turning to the diagnostic method claims, the court found that method claims drawn substantially to comparing or analyzing DNA sequences that involve only abstract mental steps not to be patent-eligible matter under 35 U.S.C. § 101. The court found that the claimed diagnostic methods to be indistinguishable from the claims the Supreme Court found invalid under §101 in Mayo. Applying Mayo, the court reasoned that the steps of administering and determining, combined with a correlative "wherein" clause are not sufficiently transformative of what was otherwise a claim to natural law.
With regard to the screening method claim, the court found that a method claim that recites a transformed cell (e.g., by insertion of a foreign DNA to the cell) to be eligible subject matter under 101. The court noted that Myriad's transformed cells, much like the patent-eligible cells in Chakrabarty, are not naturally occurring. Applying the reasoning from Mayo, the court stated that a claim featuring a transformed cell does not simply apply a law of nature. According to the court, the transformed, man-made nature of the underlying subject matter (i.e., the transformed cell) makes the method claim patent-eligible subject matter.
Impact of the Decision
In upholding the patent eligibility of isolated DNA molecules, the Myriad decision affirmed the PTO's established practice of granting patent protection for such molecules. It is unlikely, however, that the court's decision will be the last word on the patent eligibility of isolated DNA molecules. Reconsideration by the Federal Circuit en banc, and/or review by the Supreme Court, is likely.
The panel's opinion on the diagnostic method claims provides some guidance to patentees and litigants. The decision reinforces the importance of including transformative steps in diagnostic method claims. Patent applicants should ensure that all diagnostic method claims recite more than simply "analyzing" or "comparing" steps. Claims should explicitly include transformative steps, such as using a non-naturally occurring cell. Conversely, litigants accused of infringing diagnostic method claims that lack transformative steps should consider invalidity defenses based on § 101.
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